UMIN-CTR Clinical Trial

Basic information
Public title	A evaluation study of the effect of test food on human sleep. -Open Study-
Acronym	A evaluation study of the effect of test food on human sleep.
Scientific Title	A evaluation study of the effect of test food on human sleep. -Open Study-
Scientific Title:Acronym	A evaluation study of the effect of test food on human sleep.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the effect of test food on human sleep.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	EEG during sleep (Sleep scope)
Key secondary outcomes	The Japanese version of the Pittsburgh Sleep Quality Index OSA sleep inventory MA version Visual Analogue Scale

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take test food once a day, 2 capsules, for 4 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	30 years-old <=
Age-upper limit	60 years-old >
Gender	Male and Female
Key inclusion criteria	1. Males and females from 30 to 59 years of age. 2. Subjects with a PSQI-J global score of 6 or higher at the time of screening test. 3. Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria	1. Subjects who are currently under treatment for sleep, stress and fatigue, and who are using medicines and health foods related to sleep, stress and fatigue. 2. Subjects who consistently drink more than the appropriate amount of alcohol (about 20 g of pure alcohol per day). 3. Subjects who aren't abele to stop eating foods and drinks high in caffeine from 15:00 to bedtime during this research period. 4. Subjects who are midnight-shift worker or shift worker. 5. Subjects who are suffering from, undergoing treatment for, or with a history of serious diseases such as diabetes, kidney / liver disease, heart disease or thyroid disease, adrenal disease, and other metabolic diseases. 6. Subjects who have chronic diseases and take medication on a daily basis. 7. Subjects who have a history of pollinosis or a current medical history, and who plan to use or take the drug during this research period. 8. Subjects who have been diagnosed with sleep apnea syndrome. 9. Subjects who have sensitive skin and may cause skin inflammation with adhesive plasters or adhesive tape. 10. Subjects with implantable medical devices such as cardiac pacemakers and implantable cardioverter-defibrillators. 11. Subjects who have a history or current condition of drug or alcohol dependence. 12. Subjects who are pregnant or breast-feeding, or have the will of pregnancy during this research period. 13. Women with severe symptoms such as menstrual pain and premenstrual syndrome. 14. Subjects who have food allergy. 15. Subjects who are judged to be inappropriate as research subjects by blood tests in screening tests. 16. Subjects who participate in other clinical trials, who have participated in other tests within one month of obtaining consent, or who are willing to participate. 17. Subjects who plan to travel abroad, including overseas travel, during this research period. 18. Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yoshitaka Middle name Last name Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Zip code	103-0001
Address	Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo
TEL	03-3452-7733
Homepage URL
Email	eigyou27@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	TEIJIN LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17 Joto-machi, Maebashi-shi, Gumma
Tel	027-212-5608
Email	sagawa@mc-connect.co.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 11 Month 29 Day
Date of IRB	2021 Year 12 Month 02 Day
Anticipated trial start date	2022 Year 01 Month 10 Day
Last follow-up date	2022 Year 03 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 07 Day
Last modified on	2022 Year 03 Month 30 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053139